A Prospective, Open Label Study Evaluating JUVÉDERM® VOLBELLA With Lidocaine Treatment for the Correction of Skin Depressions in the Infra-orbital Area

Allergan

Status: Completed

Conditions: Infra-orbital Skin Depressions

Treatments: Device: VOLBELLA® with lidocaine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02176421

MAF-AGN-MED-FIL-020

Details and patient eligibility

About

A prospective, open label, study evaluating JUVÉDERM® VOLBELLA with lidocaine treatment for the correction of skin depressions in the infra-orbital area (under the eyes)

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has Grade > 0 at screening within each eye (bilateral skin depression in the infra-orbital area), as evaluated by the Evaluating Investigator (EI) using AIRS
• Agree to refrain from undergoing other antiwrinkle/volumizing treatments in the upper two-thirds of the face (eyebrow to cheeks/cheekbones) for the duration of the study

Exclusion criteria

• Has undergone cosmetic facial procedures [e.g., face-lift, or other surgeries which may alter the appearance of the infra-orbital area (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures), tissue augmentation with dermal fillers or fat injections, or mesotherapy] anywhere in the face, or Vistabel® cosmetic injections in the peri-orbital area, within 6 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study. NOTE: Prior treatment with HA fillers and/or collagen is allowed, provided the treatment was administered more than 12 months prior to study entry
• Has undergone volumizing of the mid face within 12 months prior to study entry
• Has ever received semi-permanent fillers or permanent facial implants (e.g., calcium hydroxylapatite, poly-L-lactic acid, polymethylmethacrylate, silicone, expanded polytetrafluoroethylene) anywhere in the infra-orbital area, or be planning to be implanted with any of these products at any time during the study
• Have a history of skin cancer
• Have a history of hypertrophic scarring
• Have a subcutaneous retaining structure on the face (e.g., meshing, gold strand)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

VOLBELLA® with lidocaine

Experimental group

Description:

Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.

Treatment:

Device: VOLBELLA® with lidocaine